The document discusses commercialization services for emerging biotechnology developments and medical devices. It introduces Secure BioMed Evaluations and Lassiter & Associates, who have expertise in bringing medical devices to market. Their services include evaluating commercial feasibility, regulatory pathway analysis, manufacturing analysis, reimbursement support, market validation, and market sizing to help clients expedite the process of getting products to market.

1. Speeding towards Commercialization

2. Commercialization Services: The difference between a great idea and a commercial success Is my “great” invention commercially feasible? What do I need in place to make VCs say “Yes!”? How can I get my product to market faster? Emerging Biotechnology developments must be studied carefully to fully define both their potential and pitfalls.

3. WHO ARE WE?

4. Secure BioMed Evaluations Founded in 1997 by Linda Braddon Ph.D. Georgia Tech in Mechanical Engineering Specializing in Tissue Engineered orthopaedic and vascular implants. Track record of bringing medical devices to market Co-inventor on a medical device that is CE marked in Europe and in the process of coming to the US markets. Served as the core engineering talent of numerous start-up medical device companies.

5. Secure BioMed Evaluations Significant Medical Device Experience Strength of Design Evaluate risk via FMEA Identify synergistic technology Manufacturing Issues Transition from bench-top to prototype to Commercialized Manufacturing Assess in-house versus contract manufacturing Regulatory Pathway Create Mechanical Test Plans Authority on applicable standards (ASTM / ANSI / ISO) and FDA guidances Design of ASTM orthopaedic standards Coordinate non-clinical testing: Biocompatibility and Mechanical Testing

6. Lassiter & Associates Founded in 1994 by Nancy (Lassiter) Chambers Atlanta-based market research firm Clientele is nationwide Serves technology and healthcare industries Regarded as experts on methods, processes, and strategic use of market validation Services include market validation , win-loss analysis, market sizing, business plans and customer retention studies.

7. Lassiter & Associates Significant Healthcare and Technology Market Experience Career began at Emory School of Medicine Set up and ran an assay laboratory Corporate experience includes IBM, ISA, Arthur Andersen, Inforum, Medirisk All areas of sales and marketing Ran national sales forces Built business unit from start to sale $50 M in technology purchases first year at Inforum All segments of Healthcare Physicians, Hospitals, Payers, Disease Management L&A clients include Healthways, Technology Association of GA, HealthSystems, DoctorQuality, and more

8. Building a Strong Foundation… Solid Technology Strong Market Demand Seasoned Management Team Risk Assessment / FMEA Manufacturing Process Regulatory Requirements Involvement of Thought Leaders Reimbursement Potential Quality Control Unmet Need Protected IP Adequate Funding Investment Potential Synergistic Technology? Successful Medical Device Company

9. How We Can Help! Solid Technology Strong Market Demand Seasoned Management Team Risk Assessment / FMEA Manufacturing Process Regulatory Requirements Involvement of Thought Leaders Reimbursement Potential Quality Control Unmet Need Protected IP Adequate Funding Investment Potential Synergistic Technology?

10. Timeline to Commercialization: Step 1 – Finding Money Market Validation + Regulatory Pathway Analysis + Manufacturing + Reimbursement 12 to 24 months 4 months Average Time for Part Time Efforts by Inventors & Staff SBME / Lassiter Team Lost Time in Commercialization The most important aspect of a successful medical device company is getting to market quickly!

11. How do we help? Expertise without the full time payroll Regulatory experience and contacts Proprietary manufacturing database Market validation to support fund raising Faster time to market

12. Our package of feasibility services BioTech Commercial Feasibility Services Regulatory Feasibility Manufacturing Analysis Reimbursement Support Market Validation Market Sizing

13. How we can Help: Regulatory Support Identify regulatory issues for approval and quality control Evaluation of key risk factors through FMEA Identification of ASTM / ISO / ANSI standards for testing Identification of FDA guidance documents for device or components What are user specified requirements for a successful device? Risk Assessment: How could the device fail? This will define how the device is tested. Are there predicate devices? Are you a second comer to the market with a clearly paved pathway or are you blazing a new trail? What are the applicable standards and guidances? Justifications for how and what to test. Proof of concept and identification of potential regulatory hurdles

14. How we can Help: Manufacturing Analysis Meet process validation requirements and identifies most feasible means of production Bench top to Commercial Manufacturing Components Contract Manufacturer Identification via SBME proprietary database Cost estimation of In-house production vs. contract manufacturing Domestic versus overseas production Process Validation Requirements (FDA requirement) Game plan for process safety and validation are mandatory for an FDA approved process

15. How we can help: Reimbursement Support Jump start analysis of the reimbursement landscape Access to our database of reimbursement experts by specialty Preparation of Reimbursement Product Packet to support reimbursement activities Allows you to expedite the approval process

16. How we can help: Market Validation Validates market potential by feedback from Domestic and international markets Thought leaders – potentials for medical advisory board Physicians that are potential buyers / users – potentials for clinical trial leaders Proof of marketability is a key component of investor presentations and the business plan. Is there sufficient demand? What is the unmet need? Who will use and in what cases? What objections will have to be overcome? What alternative solutions will compete for market share? How do demand and interest vary by country?

17. How we can help: Market Validation Market Validation Process Identification of thought leaders Secondary research and client input Feedback is obtained via Internet-based survey Product is introduced via streaming video Script assistance from SecureBNE and L&A Inventor describes in his / her own words Trends analyzed and identified Drill-down interviews conducted for better understanding of underlying issues Validation report contains hard data + qualitative findings Lowers investment risk in new technology Hard data provides indisputable proof of marketability

18. How we can help: Market Sizing Quantifies the potential number of devices to be sold Measures the size of markets and segments Identifies future potential What is the size of the physician market? What is the size of the patient market driving usage? What is the growth rate of the market segments? How does the market vary by country? Market sizing drives realistic revenue forecasts Large, growing market(s) = ingredient for commercial success

19. Building a Strong Foundation… Solid Technology Strong Market Demand Seasoned Management Team Risk Assessment / FMEA Manufacturing Process Regulatory Requirements Involvement of Thought Leaders Reimbursement Potential Quality Control Unmet Need Protected IP Adequate Funding Investment Potential Synergistic Technology? Successful Medical Device Company

20. Snapshot of a Successful Medical Device Company with Us on Your Team…. Market Validation Who, what, where and why the product will be used Identification of Physician Thought Leaders Clear View of Regulatory Pathway Predicate Devices Applicable testing standards and guidances Reimbursement Manufacturing Bench-top to Prototype to Final Product In-house versus contract manufacturing US or Overseas Solid Technology Novel Protected IP Fills an unmet need Seasoned Management Team Proven track record Understands the business of science Understands importance of Advisory Board Our Work… Your Work…

21. What you get: Commercialization Study Deliverables Mitigates of risk through extensive failure analysis Medical Advisory Board Clinical Trial Leaders Indentifies regulatory hurdles Expedites the approval process Indisputable proof of marketability Drives realistic revenue forecasts Early insight to preferable manufacturing pathway

22. What you get: A n expedited path to commercial success Faster to funding. Faster to market. Faster to profitability. From a good idea…. To a well funded company…